Antibiotic

Product NDC
36800-536
11-digit product format
368000536
Labeler code
36800
Product ID
36800-536_3c4b9bbd-b6bf-4e7d-880e-c4c360ca739a
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-03
Substance
BACITRACIN
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii58H6RWO52I
Rxcui1648110

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-536-64Antibiotic1 in 1 CARTONOINTMENT14
36800-536-64Antibiotic28 g in 1 TUBEOINTMENT284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-536-64GM - Gram36800-5366ea2a097-529d-4e51-8da6-1f8863450c6a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-536ANTIBIOTIC (BACITRACIN) OINTMENT [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20240925_3267a695-9e53-42f2-b30a-022653a0b8bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN3267a695-9e53-42f2-b30a-022653a0b8bb4
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD3267a695-9e53-42f2-b30a-022653a0b8bb4
1648110bacitracin 500 UNT per GM Topical OintmentSY3267a695-9e53-42f2-b30a-022653a0b8bb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-536-64368000536641 TUBE in 1 CARTON (36800-536-64) / 28 g in 1 TUBE1 tube2020-04-030000-00-00NoNoCurrent